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CTRI Number  CTRI/2013/03/003486 [Registered on: 15/03/2013] Trial Registered Prospectively
Last Modified On: 13/03/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   effect of taping on quadriceps strength in patients with osteoarthritis 
Scientific Title of Study   Efficacy of kinesio taping on isokinetic quadriceps torque in knee osteoarthritis: a double blinded randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
26101987  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASudarshan 
Designation  post graduate student 
Affiliation  Coventry university 
Address  Department of physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054

Bangalore
KARNATAKA
560054
India 
Phone    
Fax    
Email  anandkumar.sudarshan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs SHOBHALAKSHMI  
Designation  Assistant professor 
Affiliation  Coventry university 
Address  Department of physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054

Bangalore
KARNATAKA
560054
India 
Phone  9008025432  
Fax    
Email  msrmcpt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mrs SHOBHALAKSHMI 
Designation  Assistant professor 
Affiliation  Coventry university 
Address  Department of physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054

Bangalore
KARNATAKA
560054
India 
Phone  9008025432  
Fax    
Email  msrmcpt@gmail.com  
 
Source of Monetary or Material Support  
MS Ramaiah medical teaching hospital 
 
Primary Sponsor  
Name  MS Ramaiah hospitals 
Address  Department of Physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
None  none 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ASudarshan  Out-patient departments of Orthopaedics and Physiotherapy - M.S Ramaiah Hospitals  MS Ramaiah hospitals, MSRIT post, MSR nagar, Bangalore - 560054
Bangalore
KARNATAKA 
8431131061

anandkumar.sudarshan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah medical college and hospitals ethical review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Knee osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sham Kinesio taping  For the control group receiving sham taping, the directions of the tape application with the three “I” strips are the same as the experimental group. However, no stretch will be applied in the tape and the knee will not be flexed for the paper off application. That is, the tape will be stuck as such on the knee with no activation of the glue.  
Intervention  Therapeutic Kinesio taping  For therapeutic KT application, three “I” strips were taken and applied. The base of the first strip was applied 10 cm below the anterior superior iliac spine. Following this, the tape was pulled with a 50% - 75% tension along the course of the rectus femoris until the superior border of the patella. The knee was then flexed to 45 degrees with the remaining strip applied in a paper-off tension (without tension) extending over the superior border of the patella. The base of the second “I” strip was applied below the greater trochanter and the tape was pulled with a 50% - 75% tension along the course of the vastus lateralis until the lateral border of the patella. Following this, the knee was flexed to 45 degrees and the remaining strip was applied with a paper-off tension (without tension) around the lateral border of patella towards the tibial tuberosity. The base of the third strip was applied from the middle 1/3rd of the medial aspect of the thigh. The tape was pulled with a 50% to 75% tension along the course of vastus medialis towards the medial border of the patella. Following this, the knee was flexed to 45 degrees and the remaining strip was applied with a paper off tension (without tension) around the medial border of patella ending towards the tibial tuberosity. After application of the tape, they were rubbed upon with paper to activate the glue. The tape will be removed immediately after measuring the primary and secondary outcome measures. The tape will be applied only once.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age group – 40 to 65 years
2. Sex- Both males and females
3. Diagnosis according to American College of Rheumatology criteria
4. Radiographic severity according to the K-L scale ≤ grade 2
 
 
ExclusionCriteria 
Details  1. Clinical evidence of Varus / Valgus malalignment
2. Neurological deficits
3. Subjects who are undergoing any physiotherapy treatment for the current knee pain
4. Infectious / systemic arthritis of the knee
5. Any pathology preventing isokinetic testing (eg. Lumbar nerve root compression, myopathy).
6. Language / cognitive deficits that might limit the informed consent
7. Current or past (within 4 weeks) use of oral corticosteroid
8. Knee surgery or intra-articular corticosteroid injection within the past 6 months
9. Knee instability or sensation of knee “giving out”
10. Unable to ambulate without gait aid
11. Presence of other disorders affecting the lower limbs (such as plantar fascitis)
12. History of treatment with Kinesio tape application
13. History of any skin allergy
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
peak quadriceps torque (measured using an isokinetic dynamometer) concentric and eccentric contraction at angular velocities of 90 degrees per second and 120 degrees per second  Pre taping and immediate post taping 
 
Secondary Outcome  
Outcome  TimePoints 
Standardised stair climbing task (SSCT) and visual analogue scale (VAS)  Pre taping and immediate post taping 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   "None yet" 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Rationale: The knee joint is commonly affected in osteoarthritis where the strength of the quadriceps muscle and its torque producing capability is frequently found to be compromised. Recently, the use of kinesio taping as an intervention in musculoskeletal disorders has become popular amongst physiotherapists. However, its ability to improve the isokinetic knee performance has conflicting results in literature with only few studies showing an increase in the quadriceps torque. This warrants further investigation in knee osteoarthritis, forming the basis for this study. Objective: To compare the isokinetic quadriceps torque, standardized stair-climbing task and pain between subjects in experimental and control group before and after kinesio tape application. Materials and method: A double blind pre-test post-test control group design will be followed where 40 subjects will be randomly allocated to either the experimental or control group. Subjects will be recruited from the out-patient departments of orthopaedics and physiotherapy-MS Ramaiah Hospitals using random sampling. The dependent variables for this study are peak quadriceps torque (measured using an isokinetic dynamometer), standardized stair-climbing task (where the time taken to ascend and descend 5 stairs “as quickly and as safely” as possible would be noted) and pain (measured using the visual analogue scale). A pre test measurement of the variables will be carried out by a blinded assessor following which the kinesio tape application will be done by the principal investigator. The blinded assessor will then carry out the post test measurement of the same variables. Statistical method: Descriptive statistics will be used to compare the baseline characteristics of the experimental and the control group (utilizing mean and standard deviation). Student t test (unpaired) will be used to compare the peak quadriceps torque values and the time taken in the standardized stair climbing task between the experimental and control group. The Student t test (paired) will be used to analyze the within group variations for the same. Mann-whitney U test will be used to compare the pain scores of VAS between the experimental and control group with the Wilcoxon signed-rank test used to compare the within group variations.

 
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